Histogenics has enrolled 123 (>50%) of the 245 patients required to complete enrollment in its ongoing NeoCart® Phase III clinical trial. This trial is being conducted under a Special Protocol Assessment with FDA.
Company leadership attributes its progress to enrollment-enhancing strategies implemented in 2015, as well as changes by FDA in 4Q15 to the Phase III clinical trial inclusion/exclusion criteria. Trial enrollment is expected to complete in 2Q17.
The trial is investigating NeoCart autologous cell therapy vs. microfracture as a first-line approach for the treatment of full thickness adult knee cartilage defects.
Source: Histogenics Corporation